Contraceptive apparatus and procedure

ABSTRACT

An instrument for implanting a ring in the tissue around the intramural portion of the Fallopian tube and the method of closing the canal of the intramural portion of a Fallopian tube with a ring. The instrument is an elongated member having an annular knife surrounding a forwardly projected guide rod. The knife is located at the forward edge of a cylindrical member used to carry the expanded annular device, as an elastic ring. The knife is used to make an annular incision in the intramural tissue of a Fallopian tube. The instrument has a second movable member for removing the expanded ring past the knife, thereby implanting the ring in the annular incision made by the knife. The ring returns to its original position, thereby closing the canal of the Fallopian tube.

United States Patent 1191- Bolduc 1 CONTRACEPTIVE APPARATUS AND Dec. 24, 1974 3,760,810 9/1973 Van Hoorn 128/303 A PROCEDURE [75] Inventor: Lee R. Bolduc, St, Louis Park, Primary Exammer Dalton Truluck Minn' 57 BSTRACT A [73] Assignee: Medtronic, Inc., Minneapolis, Minn. 1

An instrument for 1mplant1ng a ring 1n the tissue Flledi Man 1, 1973 around the intramural portion of the Fallopian tube [2]] Appl NOJ 337,071 and the method of closing the canal of the intramural portion of a Fallopian tube with a ring. The instrument is an elongated member having an annular knife sur- 128/1 0 A, 0 rounding a forwardly projected guide rod. The knife is located at the forward edge of a cylindrical member Field M Search 128/l R, 303 A, 305, 306, used to carry the expanded annular device, as an elas- 123/310, 311, 326, 346; 30/124 tic ring. The knife is used to make an annular incision in the intramural tissue of a Fallopian tube. The in- References Cited strurnent has a second movable mernber for removing UNITED STATES PATENTS the expanded ring past the knife, thereby implanting 823,877 6/1906 Kellogg 128/326 the n in the annular incision made y the knife- The 2,473,968 '6/1949 Paton..... 128/305 g returns to its original posit on, the eby closing the 2,840,082 6/1958 Salvatore 128/303 A canal of the Fallopian tube. 3,675,639 7/1972 Cimber 123/1 R 3,680,542 8/1972 Cimber 128/1 R 15 Clam, 9 Drawmg F' 1/ e I I JV W 44 ///1/ lll77 /&\ p /6 Z 39 7 26 v 3/ 1 CONTRACEPTIVE APPARATUS, ANDPROCEDURE BACKGROUND OF THE INVENTION A common surgical procedure to sterilize a female primate is a procedure wherein each Fallopian tube is severed and tied to block the oviduct and thereby preventova from entering the uterus. This procedure includes placing the patient under general anesthesia and making an abdominal incision of 8 to centimeters in the pubic region to provide access to the body cavity. After severing and tying the Fallopian tubes, the incision is closed with clamps and stitches. This requires a period of hospitalization and is extremely uncomfortable and painful to the patient.

Mechanical contraceptive devices are used for temporarily sterilizing a female. These devices include plugs which are inserted into-the oviduct of the Fallopian tube to prevent the ova from passing through the duct of the tube. The plugs do not insure that the ova cannot flow through the duct of the tube into the uterus. Also, the plugs may be dislodged and lostwith- .out the female being aware of it. There is no assurance SUMMARY OF THE INVENTION The invention is related to an instrument or tool for implanting an annular device in the tissue around the canal of a Fallopian tube to close the canal of the Fallopian tube, thereby preventing ova from flowing down the tube into the'uterus. The instrument has a first means for making an annular incision in the tissue around the exit section of the canal of the Fallopian tube. The first means has a-member for carrying an expande'd annular device and a knife means for cutting an annular incision. A second means movable relative to the first means is used to remove the annular device from the member and place the annular device in'the incision. The annular device, when removed from the member, contracts to its original size, thereby closing the canal of the Fallopian tube. The annular device is removed from the instrument in a manner whereby the annular device is placed in the incision to locate the annular device in the muscle tissue around the canal of the Fallopian tube. The muscle tissue will reunite, thereby embedding the annular device in the tissue so that the annular device will not be dislodged or' inadvertently removed to reopen the canal of the Fallopian tube.

The invention also includes the method of closing the canal of a Fallopian tube with an annular contracting device. An annular incision is made in the tissue around the intramural or exit portion of the Fallopian tube by inserting an instrument having an annular knife into the uterine cavity. The instrument is guided into the canal to make an annular incision concentric about the canal. The expanded annular device is placed in the annular incision. The expanded annular device is allowed to contract while it'is located in the annular incision to close the canal of the Fallopiantube. The instrument is removed from the uterine cavity with the annular. de-

vice embedded in the tissue surrounding the canal of the Fallopian tube. The tissue will heal and thereby permanently embed the annular device in the tissue around the canal of the Fallopian tube.

Itis an object of the invention to provide an apparatus and procedure whereby the canal of a Fallopian tube can be permanently closed without making an incision in the body cavity. Another object of the invention is to close the intramural portion of the Fallopian tube with an annular contracting device that is placed about the canal of the Fallopian tube from the uterine cavity. A further object of the invention is to provide a device which is implanted in the muscle tissue of a Fallopian tube that will not dislodge and permanently close the canal of the Fallopian tube. A still further object of the invention is to provide a device for closing the canal of a Fallopian tube which does not interfere with the normal erection and ,contractionof the Fallo pian tubes.

IN THE DRAWINGS FIG. 1 is a side elevational view of the cutting and insertion instrumentof the invention in the cutting position; I v

FIG. 2 is a side elevational view similar to FIG. 1 showing the instrument in theposition fo r inserting the ring in an incision to close the canal of a'Fallopian tube;

FIG. 3 is an enlarged end view of the cutting end of the instrument of FIG. 1;

FIG. 4 is a sectional view of a part of the uterus and Fallopian tube of a female primate;

FIG. 5 is a sectional view showing the instrument making an annular incision into the uterus tissue around the Fallopian tube;

FIG. 6 is a sectional view taken along the lines 6-6 of FIG. 5;

FIG. 7 is a sectional view similar to FIG. 5 showing the ring removed from the instrument;

FIG. Sis a sectional view similar toFIG. 7 with the instrument removed from the uterus; and,

FIG. 9 is a sectional view taken along the line 99.

of FIG. 8. v

Referring to the drawings, there is shown in FIGS. 1 and 2 an instrument It) for implanting an annular contracting device or member, as a ring, around the canal or aqueduct of a Fallopian tube to close the .canal and thereby prevent the passage of ova through the canal. Instrument 10 has a first member indicated generally at 11 operable to cut an annular incision in the exit portion or intramural portion of the Fallopian tube and a second member indicated at 12 movably mounted on the first member to implant an annular contracting device, as a ring, to close the canal of the Fallopian tube. The closed canal and annular incision in the tissue about the canal will heal forming tissue which embeds the annular device in the tissue. The annular device cannot remove itself and thereby reopen the canal of the Fallopian tube.

First member 11 has a crylindrical body 13. The outer end of body 13 has an annular or circular knife 14. A cylindrical recess 16 extends axially into the body 13 whereby the outer portion of the body is a cylindri-' cal sleeve or collar. The outer portion or-surface of body 13 has a smooth cylindrical configuration. Se

cured to the body 13 is a guide means or rod 17. Rod 17 extends axially through recess 16 and terminates in a point 17A located outwardly from the knife 14. Knife 14 is concentrically located about the rod 17.

Cylindrical body 13 is attached to an elongated linear member or rod 18. The end of member 18 is attached to a cylindrical head'1 9. The member 18 extends into head 19 and is attached thereto with a fastener 20.

Second member 12 is slideably disposed on the cylindrical body 13 and elongated linear member 18. Second member 12 is a one-piece plastic unit having an elongated body 21with a longitudinal passage 22 for slideably accommodating linear member 18. One end of body 21 has a cylindrical recess 23 forming a sleeve 24 concentrically positioned about the cylindrical body 13.Sleeve 24- terminates in a circular end 26 surround-' ing the cylindrical outside wall of the body 13. The recess 23 has a longitudinal length which allows the cylindricalbody 23 to be longitudinally moved relative to the body 21 whereby the end 26 will move past or outwardly of the knife 14 as shown in FIG. 7.

The instrument 10 is used to implant an annular elastic contracting device or member 27, as a ring or torus of plastic or metal. The member 27 is made of bio-inert material which can be expanded and will contract to its initial shape. Examples of the material are Silastic plastic and stainless steel. Other materials can be used for the annular device 27. The annular device 27 shown in FIGS. 5-9 is an elastic ring of plastiematerial having a uniform circular cross section. Ring 27 can be expanded or enlarged to place it on the cylindrical member 13 adjacent end 26 of the second member. When ring 27 is removed from member 13, it contracts or returns to its original size. A cap 45 shown in broken lines in FlG.-1 placed on rod 17 andcovering knife 14 is used to load the ring 27 on member 13.

Referring 'to FIG. 4, there is shown a section of a uterus 28 of a female. Uterus 28 has a top-portion or fundus '29 and a body 31. The entire uterus is a pearshaped, thick walled, hollow organ situated-between the bladder and rectum. The uterus 28 has a uterine cavity 32 which is flattened and triangular in shape.

The uterine wall is'composed of an outer serosal layer 30, or peritoneum, a firm, thick, intermediate coat of smooth muscle 33 or myometrium,and an inner mucosal lining 34 or endometrium.

Leading to the upper part of the uterus are Fallopian tubes 36. The Fallopian tubes are paired, trumpetshaped muscular canals which extend from the superior angles of the uterine cavity to the ovaries. The ovaries, not shown, are solid, slightly irregular shaped bodies situated on either side of the uterus behind and below the Fallopian tubes.

Fallopian tube 36 is a musculomembranous structure about 12 cm in length commonly divided into isthmus 37, intramural 38 and ampullary sections (not shown). The tube 36 has an aqueduct or canal 39 providing a passage for the movement of ova from the ovaries into the uterus. The intramural section 38 traverses the uterine wall in more or less straight fashion. It has an ampulla-like dilation just before it communicates with the uterine cavity 32. The canal 39 is the narrowest at the intramural section 38. The isthmus section 37 is long and wavy and the canal is not as narrow as the canal in the intramural section. The wall of the Fallopian tube consists of three layers, a serosal coat, a muscular layer and a mucosa] lining. The muscular lining 4. includes longitudinal muscle fibers which, when contracted, bring the ends of the Fallopian tubes into close contact with the surface of the ovaries. Blood vessels are abaundant in the muscular layer where they form with the muscle bundles a kind of erectal tissue which, if engorged, enables the Fallopian tube to sweep over the surface of the'ovary. This action of the Fallopian tubes is impaired when the tubes are severed and tied. The closing of the intramural section of the Fallopian tubes with the annular device 27 according to the invention does not interfere with the erectal action of the Fallopian tubes.

In use, the instrument 10 is equipped with an elastic annular device 27, such as a Silastic ring. The ring 27 is placed about the cylindrical body 13 adjacent the end 26 of the sleeve 24. This is accomplished by moving ring 27 over cap 45 onto the cylindrical body 13. The cap 45 is then removed. The instrument l0 carrying the expanded annular device 27 is inserted into the uterine cavity 32. The cylindrical body 13 is directed toward the outlet of the canal 39 of the Fallopian tube j 36. The rod 17 is moved into the canal 39 to guide the instrument and locate the circular cutting knife 14 concentric with the canal 39. j

Referring to FIG. 5, the cylindrical body 13 is rotated, as shown by arrow 41, as it is moved into the tis-' sue forming an elongated-circular incision 42. Incision 42 is in the muscular tissue surrounding the canal 39 and is radially spaced from the outer walls of the aqueduct to leave a core of muscle tissue 43. The incision 42 is approximately] to L5 mm in length.

Referring to FIG. 7, the annular elastic device 27 is removed from cylindrical body 13. The second member 12 is moved in the direction of arrow 44 while the first member 11 is held in a stationary position. The sleeve 24 moves outwardly along the cylindrical body 23, moving the annular device 27 past the knife edge 14. This places the annular device 27 at the base of the circular incision 42. The annular device 27, being expanded, will contract to its normal-size and thereby contract the muscle tissue about the rod 17. This implants the annular dev-ice 27 in the canal 39. I I

As shown in FIG. 8, the instrument 10 has been removed from the uterus. The annular device 27 is contracted, closing the canal 39. The core of muscle tissue 43 closes the incision 42 rearwardly of the annular device 27. The annular incision will intime heal and provide a permanent closure of the opening of the canal 39. Part of the tissue 43 will slough off. The remaining tissue will permanently cover the annular. device 27 and close canal 39.

While there have been shown and described a preferred embodiment of the instrument for implanting a 1 ring to close the aqueduct of a Fallopian tube and a method of inserting the ring around the aqueduct of the Fallopian tube, it is understood that modifications and alterations in the instrument as well as the method may be made by those skilled in the art without departing from the invention. The invention is defined in the following claims.

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:

1. An instrument for implanting an annular device in tissue around the canal of a Fallopian tube to close the canal of the Fallopian tube comprising: first means fortissue around the making an annular incision in the tissue around the exit section of the canal of the Fallopian tube, said first means having a member for carrying an expanded annular device and knife means for cutting the annular incision in the tissue, and second means movable relative to the first means for moving the annular device from the member and into the annular incision in the tissue around the-canal whereby said annular device contracts closing said canal.

2. The instrument of claim 1 wherein: the knife means is a circular knife at one end of the member.

3. The instrument of claim 1 including: guide means projected longitudinally outwardly from the member to concentrically locate the knife means around the canal.

4. The instrument of claim 3 wherein: the guide means comprises an axial rod extended outwardly from the member, said knife means located concentrically about the rod.

5. The instrument of claim 1 wherein: the member is acylindrical member having an axial recess, said knife means comprising a circular sharp edge at the outer end of the recessed end of the cylindrical member.

6. The instrument of claim 1 wherein: the first means has an elongated section, said member being attached to one end of the elongated section, said second means comprising a sleeve slideably mounted on the elongated section, said sleeve having a portion surrounding the member, said portion engageable with the annular device to move the annular device from the member on movement of the sleeve relative to the elongated sectron.

tached to the other end of the elongated section.

8. The instrument of claim 1 wherein: the member is 7.The instrument of claim 6 including: a head at a cylindrical member having an elongated cylindrical outer surface, said annular device being an expandable ring locatable on said cylindrical outer surface.

9. The instrument of claim 1 wherein: the second around the canal.

means surrounds the first means and mounted thereon.

10. A method of closing the canal of a Fallopian tube with an annular device comprising: making an annular incision around the exit portion of the canal of a Fallopian tube from the uterine cavity, placing an expanded annular device in the annular incision and allowing the expanded annular device to contract to close the canal of the Fallopian tube.

11. The method of claim 10 wherein: the annular incision is made by inserting an instrument having an 'annular knife into the uterine cavity, guiding a portion of the instrument into the exit section of the canal during the annular cutting of the tissue around the canal with the annular knife.

12. The method of claim 10 including: expanding an annular device on an instrument having an annular knife, inserting the instrument carrying the annular device into the uterine cavity; said annular .incision is made by cutting an annular incision in the tissue around the canal of the Fallopian tube, said annular device is placed into the incision by moving the annular is movably device from the instrument whereby the annular device contracts closing the canal, and removing the instrument from the uterine cavity.

13. The method of claim 12 wherein: the instrument is rotatedabout its longitudinal axis during the cutting of the annular incision.

14. The method of claim 12 wherein: a portion of-the instrument is guided into the exit section of the canal during the cutting of the annular incision. v

15. The method of claim 10 wherein: the annular incision is made with an instrument having a knife portion and a guide portion, said guide portion of the instrument is inserted longitudinally into the canal to locate the knife portion concentrically about the canal whereby the knife portion makes the annular incision 

1. An instrument for implanting an annular device in tissue around the canal of a Fallopian tube to close the canal of the Fallopian tube comprising: first means for making an annular incision in the tissue around the exit section of the canal of the Fallopian tube, said first means having a member for carrying an expanded annular device and knife means for cutting the annular incision in the tissue, and second means movable relative to the first means for moving the annular device from the member and into the annular incision in the tissue around the canal whereby said annular device contracts closing said canal.
 2. The instrument of claim 1 wherein: the knife means is a circular knife at one end of the member.
 3. The instrument of claim 1 including: guide means projected longitudinally outwardly from the member to concentrically locate the knife means around the canal.
 4. The instrument of claim 3 wherein: the guide means comprises an axial rod extended outwardly from the member, said knife means located concentrically about the rod.
 5. The instrument of claim 1 wherein: the member is a cylindrical member haviNg an axial recess, said knife means comprising a circular sharp edge at the outer end of the recessed end of the cylindrical member.
 6. The instrument of claim 1 wherein: the first means has an elongated section, said member being attached to one end of the elongated section, said second means comprising a sleeve slideably mounted on the elongated section, said sleeve having a portion surrounding the member, said portion engageable with the annular device to move the annular device from the member on movement of the sleeve relative to the elongated section.
 7. The instrument of claim 6 including: a head attached to the other end of the elongated section.
 8. The instrument of claim 1 wherein: the member is a cylindrical member having an elongated cylindrical outer surface, said annular device being an expandable ring locatable on said cylindrical outer surface.
 9. The instrument of claim 1 wherein: the second means surrounds the first means and is movably mounted thereon.
 11. The method of claim 10 wherein: the annular incision is made by inserting an instrument having an annular knife into the uterine cavity, guiding a portion of the instrument into the exit section of the canal during the annular cutting of the tissue around the canal with the annular knife.
 12. The method of claim 10 including: expanding an annular device on an instrument having an annular knife, inserting the instrument carrying the annular device into the uterine cavity; said annular incision is made by cutting an annular incision in the tissue around the canal of the Fallopian tube, said annular device is placed into the incision by moving the annular device from the instrument whereby the annular device contracts closing the canal, and removing the instrument from the uterine cavity.
 13. The method of claim 12 wherein: the instrument is rotated about its longitudinal axis during the cutting of the annular incision.
 14. The method of claim 12 wherein: a portion of the instrument is guided into the exit section of the canal during the cutting of the annular incision.
 15. The method of claim 10 wherein: the annular incision is made with an instrument having a knife portion and a guide portion, said guide portion of the instrument is inserted longitudinally into the canal to locate the knife portion concentrically about the canal whereby the knife portion makes the annular incision around the canal. 